Lynparza Approval Shows Benefit/Risk Contrast In Maintenance, Relapse Settings
AstraZeneca’s olaparib gains accelerated approval for fourth-line treatment of ovarian cancer – a different indication than the maintenance claim publicly vetted and rejected by FDA’s Oncologic Drugs Advisory Committee due to the drug’s toxicities and concerns about the reliability of progression-free survival data.
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Tesaro's niraparib has an advantage over other PARP inhibitors in that it has been tested successfully in Phase III for ovarian cancer patients with and without BRCA mutations, but AstraZeneca thinks it may have a case for broad labeling without pivotal data in this population.
AstraZeneca hopes "robust" data from its Phase III SOLO-2 trial will pave the way for its PARP-inhibitor Lynparza (olaparib) to be used in the US market as a maintenance therapy in BRCA-mutated second-line ovarian cancer. But some analysts think FDA may want more proof before giving the okay.
Myriad’s myChoice HRD test has demonstrated its ability to identify more than twice as many ovarian cancer patients who may benefit from treatment with Tesaro’s drug investigational drug niraparib, compared with patient stratification by germline-BRCA testing alone.